Vertex
Biotechnology
MS&TSeniorManager–DrugProduct
“MS&T Senior Manager – Drug Product at Vertex. Skills: Aseptic processing, Process validation. Serve as technical lead for sterile drug product. Provide scientific and engineering oversight”
What You'll Achieve.
Ensure compliant operations; Ensure robust operations; Ensure efficient operations
Industry & Context.
Problem-solving; Root cause analysis; Risk-based decision-making
What They're Looking For.
Must Have
Bachelor's degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, Microbiology, or a related scientific or engineering discipline, 8+ years of experience in pharmaceutical or biopharmaceutical manufacturing, Significant experience in sterile drug product manufacturing, 3+ years of people management experience or equivalent experience leading complex cross-functional initiatives
Nice to Have
Advanced degree (MS, PhD, or PharmD) preferred
What You'll Do.
Serve as technical lead for sterile drug product
Provide scientific and engineering oversight
Lead troubleshooting of manufacturing issues
Implement sustainable technical solutions
Lead technology transfer activities
Author and review technology transfer documentation
Support scale-up activities
Ensure readiness for manufacturing campaigns
Lead or oversee process validation strategies
Support PPQ execution
Support continued process verification activities
Support or lead hold-time studies
Support mixing and filtration studies
Support container closure integrity assessments
Support compatibility assessments
Ensure sterile drug product processes remain validated
Provide on-the-floor MS&T support
Provide remote MS&T support
Partner with Operations to improve yield
Partner with Operations to improve cycle time
Partner with Operations to improve batch success rate
Partner with Operations to improve operational efficiency
Support deviation investigations
Support OOS/OOT events
Support change controls
Ensure all activities comply with cGMPs
Ensure all activities comply with regulatory expectations
Ensure all activities comply with internal quality systems
Support regulatory filings
Support health authority inspections
Author technical sections for filings
Review technical sections for filings
Respond to health authority questions
Collaborate closely with Quality Assurance
Assess process impacts related to changes
Assess process impacts related to deviations
Assess process impacts related to validation outcomes
Manage MS&T scientists and engineers
Develop MS&T scientists and engineers
Provide technical guidance
Lead cross-functional teams
Influence stakeholders
Drive a culture of technical rigor
Drive a culture of collaboration
Drive a culture of continuous improvement
How You'll Work.
Team & Collaboration
Cross-functionally with Manufacturing; Cross-functionally with Quality; Cross-functionally with Regulatory; Cross-functionally with Supply Chain; Cross-functionally with Engineering; Cross-functionally with CMOs/CDMOs; Cross-functional teams; Manufacturing; Quality; Process Development; Regulatory; Supply Chain
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management
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